# K112648: Asfora Bullet Cage

- Pathway: 510(k) (Special)
- Applicant: Medical Designs, LLC
- Decided: Mar 13, 2012 after 183 days
- Product code: MAX (Intervertebral Fusion Device With Bone Graft, Lumbar)
- Device class: 2
- Regulation: 21 CFR 888.3080
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to P950019 (1996). 3 ancestors in all.
14 later devices descend from it; 3 cite it directly.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090048: Asfora Bullet Cage System, Medical Designs, LLC (2009) Summary page 1.
- P950019: Ray Threaded Fusion Cage (TFC)(TM) with Instrumentation, Stryker Spine (1996) Summary page 1.

## Most influential descendants
- K211873: PSX Interbody System (2021), 11 descendants of its own
- K222455: Calibrate LTX Interbody System (2022), 8 descendants of its own
- K231438: Calibrate PSX Interbody System, Calibrate NanoTec PSX Interbody System (2023), 7 descendants of its own
- K223611: Calibrate LTX Interbody System (2023), 7 descendants of its own
- K242364: IdentiTi™ II Interbody System (2024), 4 descendants of its own

## Indications for use
The Asfora Bullet Cage is indicated for spinal fusion procedures in skeletally mature patients with degenerative disc disease (DDD) and instability in the lumbar spine at one or two contiguous levels from L2 to S1. DDD for lumbar systems is defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies. The DDD patients may also have up to Grade I spondylolisthesis at the involved level(s). The ABC cage devices are used with autogenous bone graft. Patients should be skeletally mature and have had at least six (6) months of non-operative treatment prior to implant. When implanted via a posterior (PLIF, TLIF) approach, this device should be used with supplemental fixation.

Source page: https://510kreport.com/device/K112648
Methodology: https://510kreport.com/methodology